MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B2070-020
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absolute pro device referenced is filed under separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2021, a percutaneous intervention was performed on the right external iliac artery.An absolute pro stent advanced and stent deployment was performed without issues noted at that time.Following, an armada dilatation catheter advanced and post-dilatation was performed without issues reported.During armada removal, resistance was met.It was then observed that the absolute pro stent had partially deployed at the target lesion and partially deployed in the sheath.The armada catheter had become stuck in the sheath and in the partially deployed absolute pro stent.All was removed, partially deployed stent, sheath, and armada catheter, as a single unit.Angioplasty was performed on the target lesion in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficulties to remove were confirmed with other observations.There were additional noted wrinkles and bunching on the balloon consistent with use and case circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determine that case circumstances are the likely cause of the reported difficulties.It is likely that the interactions with the absolute pro stent and the sheath caused limited clearance for the armada to be removed properly.The balloon most likely did not refold properly in order to be retracted and ultimately became stuck with both the stent and sheath.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11700952
• Report Number: 2024168-2021-03353
• Device Sequence Number: 11646429
• Product Code: LIT
• UDI-Device Identifier: 08717648155345
• UDI-Public: 08717648155345
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: B2070-020
• Device Catalogue Number: B2070-020
• Device Lot Number: 00604G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABSOLUTE PRO VASCULAR STENT; TERUMO 6FRENCH SHEATH
• Patient Age: 80 YR
• Patient Weight: 62